A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS
Summary
To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.
Description
Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. Doses will be adjusted to maintain minimum blood levels of the drugs.
Study Design
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Conditions
Mycobacterium Avium-Intracellulare Infection
Intervention
Ethambutol hydrochloride, Rifabutin
Location
Univ of California - Davis Med Ctr / CARES
Sacramento
California
United States
95817
Status
Completed
Source
NIH AIDS Clinical Trials Information Service
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00002343
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Mycobacterium Avium-intracellulare Infection
A nontuberculous infection when occurring in humans. It is characterized by pulmonary disease, lymphadenitis in children, and systemic disease in AIDS patients. Mycobacterium avium-intracellulare infection of birds and swine results in tuberculosis.
Rifabutin
A broad-spectrum antibiotic that is being used as prophylaxis against disseminated Mycobacterium avium complex infection in HIV-positive patients.
Mycobacterium Avium Complex
A complex that includes several strains of M. avium. M. intracellulare is not easily distinguished from M. avium and therefore is included in the complex. These organisms are most frequently found in pulmonary secretions from persons with a tuberculous-like mycobacteriosis. Strains of this complex have also been associated with childhood lymphadenitis and AIDS; M. avium alone causes tuberculosis in a variety of birds and other animals, including pigs.
Mycobacteria, Atypical
So-called atypical species of the genus MYCOBACTERIUM. They are also called tuberculoid bacilli, i.e.: M. buruli, M. chelonae, M. duvalii, M. flavescens, M. fortuitum, M. gilvum, M. gordonae, M. intracellulare (see MYCOBACTERIUM AVIUM COMPLEX;), M. kansasii, M. marinum, M. obuense, M. scrofulaceum, M. szulgai, M. terrae, M. ulcerans, M. xenopi.
Azithromycin
A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.
Clinical Trials
To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with...
To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium C...
To compare the efficacy and safety of clarithromycin combined with rifabutin, ethambutol, or both in the treatment of disseminated Mycobacterium avium Complex (MAC) disease in persons with...
To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, an...
The primary objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) b...
PubMed Articles
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Mycobacterium avium subsp. hominissuis Infection in Horses.
To the Editor: Mycobacterium avium subsp. hominissuis infection is often detected in pigs and humans (1-3). In most cases, the main sources of this agent are environmental (4,5). During the past few y...
Quantification of Mycobacterium avium subspecies in pig tissues by real-time quantitative PCR.
BACKGROUND: Mycobacterioses in animals cause economical losses and certain Mycobacterium avium subspecies are regarded as potential zoonotic agents. The evaluation of the zoonotic risk caused by M. av...
